510(k) · Cleared
ClearedThinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir, Model 332A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Diabetes Research, Inc. · FRN Pump, Infusion
Cleared on May 24, 2004 as substantially equivalent to K024056 (Applied Diabetes Research, Incorporated, 2003) after a 21-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- May 24, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991936 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK991936 3.0 ML Reservoir, Model 103/193Medtronic Minimed · 2000
- 1 generation backK024056 Sureset 3.0 ML Reservoir, Model 24-103Applied Diabetes Research, Incorporated · 2003
- This deviceK041152 Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir…Applied Diabetes Research, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991936 | 3.0 ML Reservoir, Model 103/193 | Medtronic Minimed | 2000 | — |
| −1 | K024056 | Sureset 3.0 ML Reservoir, Model 24-103 | Applied Diabetes Research, Incorporated | 2003 | — |
| 0 (this device) | K041152 | Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir, Model 332A | Applied Diabetes Research, Inc. | 2004 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K024056 | Sureset 3.0 ML Reservoir, Model 24-103Summary page 1…Classification Name: Pump, Infusion C: Predicate Device: THINSet 3.0 ml Reservoir Predicate 510(k) #: K024056 D. Device Description: with a… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K024056.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The ThinSet Reservoir is indicated for use for the infusion of medicine, including insulin, from an insulin pump. The reservoir is not intended for use with blood or blood products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041152 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041152: Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir, Model 332A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041152
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026